Veterinary medicinal product register

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Data selected by 420 Name domitor
Original name Strength Marketing authorisation number Marketing authorisation holder: ATCvet code Species More
Domitor Vet 1 mg/ml V/NRP/02/1453 Orion Corporation, Somija QN05CM91 dogs; cats

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Medetomidine hydrohloride
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Orion Corporation Orion Pharma, Somija
Date of authorisation/renewal: 16-Oct-2012
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: NRP
Package leaflet: [PDF] Skat_sadaļā_Zāļu_apraksts (27-Jan-2025)
Labelling text: [PDF] Skat_sadaļā_Zāļu_apraksts (27-Jan-2025)
Summary of product characteristics: [DOCX] Zāļu_informācija_ZA_M_LI (27-Jan-2025)

Products

ID Strength Package size Primary packaging Labelling
V/NRP/02/1453-01 1 mg/ml 1 Stikla flakons, 10 ml -
Dexdomitor 0.5 mg/ml EU/2/02/033/001 Orion Corporation, Somija QN05CM18 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Dexmedetomidine hydrochloride
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Orion Corporation Fermion, Somija
Date of authorisation/renewal: 02-Aug-2007
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/02/033/001 0,5 mg/ml 1 Stikla flakons, 10 ml -
Dexdomitor 0.1 mg/ml EU/2/02/033/003 Orion Corporation, Somija QN05CM18 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Dexmedetomidine hydrochloride
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Orion Corporation Fermion, Somija
Date of authorisation/renewal: 30-Aug-2012
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/02/033/003 0,1 mg/ml 1 Stikla flakons, 20 ml -
Dexdomitor 0.1 mg/ml EU/2/02/033/004 Orion Corporation, Somija QN05CM18 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Dexmedetomidine hydrochloride
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Orion Corporation Fermion, Somija
Date of authorisation/renewal: 30-Aug-2012
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/02/033/004 0,1 mg/ml 10 Stikla flakons, 20 ml -
Dexdomitor 0.5 mg/ml EU/2/02/033/002 Orion Corporation, Somija QN05CM18 dogs; cats Vairāk

Medicinal product information

Pharmaceutical form: solution for injection
International name (active substance): Dexmedetomidine hydrochloride
Distribution category: To be supplied only on veterinary prescription
Manufacturer(s) responsible for batch release Orion Corporation, Somija
Date of authorisation/renewal: 02-Aug-2008
Marketing authorisation valid until: Unlimited time period
Marketing authorisation procedure: EU
Package leaflet: * -
Labelling text: * -
Summary of product characteristics: * -
* More detailed information available on the European Medicines Agency website

Products

ID Strength Package size Primary packaging Labelling
EU/2/02/033/002 0,5 mg/ml 10 Stikla pudelīte, 10 ml -

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